Method and apparatus for rapid deployment chest drainage

ABSTRACT

Devices and methods are disclosed for achieving chest drainage in humans or other animals. Chest drainage is often required following traumatic injury or surgery. The devices and methods disclosed herein are especially useful in the emergency, trauma surgery or military setting. The devices utilize a chest tube with a cutting distal end and a central blunt trocar. The blunt trocar or obturator shields the sharp cutting distal end of the chest tube until controllably retracted. Once the blunt trocar or obturator is retracted, the chest tube is advanced out through its sterile, protective package and into the patient. The blunt trocar is advanced back into its position to shield the sharp tip of the chest tube during patient insertion. The chest tube also includes a hold-down mechanism that is created by an adhesive seal to the patient&#39;s chest and ribbons or straps that are wrapped around the chest tube once it is correctly positioned. The straps include adhesive ends to grip the chest tube once the straps are in place.

[0001] This application claims priority benefit under 35 USC § 119(e)from U.S. Provisional Application No. 60/447,110 filed Jun. 9, 2003, andU.S. Provisional Application No. 60/415,188 filed Sep. 30, 2002.

FIELD OF THE INVENTIONS

[0002] The inventions described below relate the fields of generalsurgery, cardiothoracic surgery, trauma surgery, combat medicine, andemergency medical services.

BACKGROUND OF THE INVENTIONS

[0003] Chest drainage tubes are flexible tubes that are placed into apatient's chest cavity to allow for drainage of fluids following traumaor surgery. These chest tubes have one or more holes at the distal endthrough which the fluid is evacuated from the chest cavity into thelumen of the chest tube. The proximal end of the chest tube includesconnectors to allow for passage of the drained fluids from the lumen ofthe chest tube into a collection device or apparatus. The chest tubes orcollection apparatus typically include features to prevent backflow ofair into the chest cavity, thus preventing pneumothorax. These backflowprevention features include shutoff valves and duckbill valves. Typicalcollection apparatus comprises gravity fed drains or vacuum or pumppowered drainage mechanisms.

[0004] Chest tubes are typically placed into a patient with a stifftrocar mounted to the internal lumen. The trocar is stiff, relativelypointed at the distal end, and allows for advancement of the flexiblechest drainage tube into an incision in the chest wall. The stiff,pointed trocar is useful for initial insertion of the chest tube butbecomes a dangerous instrument once the chest tube is advanced below thelevel of the ribs. Use of such internal trocars is not appropriate fornon-physician insertion because of the inherent danger of heart or lungperforation.

[0005] Maintenance of sterility has always been problematic with chesttubes. Placement of a chest tube, especially in the emergency setting,requires sterile scrub of the incision area and incision into the chestwall with sterile instruments. These incisions are, understandably,difficult to perform aseptically in the field, where the insertion sitemay be bloody, dirty or otherwise contaminated. In addition, maintenanceof sterility in the area of chest tube penetration into the chest hasbeen difficult as has been the ability to hold the chest tube inposition once it has been introduced into the patient. The use ofsurgical gloves to maintain sterility becomes problematic since thegloves become contaminated quickly in the typical field environment.

[0006] New devices and methods are needed to permit rapid placement ofchest tubes by less trained individuals in contaminated environments. Inaddition, improved devices and methods of maintaining sterility at thechest tube wound site and holding the chest tube in place are needed.

SUMMARY OF THE INVENTION

[0007] This devices and methods described herein provide for placementof chest tubes in contaminated environments using rapid deploymenttechniques, for maintaining sterility at the penetration site on thepatient's chest where the chest tube emerges, and for improved methodsof holding the chest tube in place. The present invention is a chesttube that is provided with a double aseptic package that maintainssterility and cleanliness of the chest tube in contaminatedenvironments. The chest tube includes a cannula with a sharpened distalend and a blunt trocar or nose cone that selectively shields or exposesthe sharpened distal end.

[0008] In another embodiment, a region on the chest tube is configuredto allow for maximum friction while gripping the chest tube through thepackage material. In another embodiment, a region on the packaging isfabricated from gripping material to facilitate pushing the chest tubeinside the packaging. The region on the packaging optimized for grippingthe chest tube is optionally fabricated from elastomeric material tofacilitate moving the chest tube inside and relative to the inelasticpackage. In another embodiment, the blunt trocar itself is shaped so asto penetrate the package without the need of a separate sharp tip. Thisblunt trocar is also suitable for blunt dissection into the chest wallonce the initial incision has been completed.

[0009] The chest tube may further include a malleable region along partor all of its length to facilitate bending of the chest tube into apre-determined shape. The use of a curved or bent shape on the part ofthe chest tube facilitates placement beneath the ribs but above thelungs and heart.

[0010] Another feature of the invention is a patch, disc, plate ormembrane of adhesive-faced impermeable material that is adhered to thesite where the wound will be created in the chest wall. The patch mayalso be coated with materials that have disinfectant properties. Thepatch also includes straps disposed, for example, in a starburstpattern. Once the site has been swabbed with disinfectant, the disc ofmaterial is adhesively placed on the skin at the site of the incision.The incision is now made through the patch of material. This patchserves as a sterile barrier following placement of the chest tube. Thestraps serve to hold onto the chest tube to maintain its position onceplaced. The straps are wrapped around the chest tube and adhesivelyaffixed to the shaft of the chest tube after placement, thus securelyholding the chest tube to the disc, which is affixed to the chest wallof the patient. The patch is optionally pre-mounted to the chest tubeinside the package. In this embodiment, the chest incision is performedprior to attachment of the patch to the patient. In another embodiment,the disc is integral to the inner packaging material so that once theouter packaging material is removed, the patch may be immediately placedagainst the chest over the region of the incision.

[0011] In another embodiment of the invention, a chest tube is designedwith an integral tip that permits the chest tube to be advanced out ofthe package by forcing a fenestration in the package wall or seal. Theintegral tip may be a cutting member that is selectively exposed by theoperator and then retracted following package penetration. This samecutting member may also be used to make the initial incision in thechest wall of the patient. The member that re-protects the cutting edgemay be a blunt nose that is suitable for bluntly dissecting the tissuebetween the ribs. In another embodiment of the invention, the blunt noseis configured to form a wedge so that it is able, itself, to force afenestration in the package or package seal, thus obviating the cuttingedge.

[0012] The chest tube package may be configured with a region thatallows for manipulation of the contents so that the chest tube may beadvanced out of the package by manual application of force. The regionpermitting manipulation is an elastic area that is deformable relativeto the rest of the package or it is a movable region with a sliding sealbetween itself and the rest of the package. Either method maintainssterility within the package during moving of the contents. The innerpackage containing the chest tube may also comprise a region that isspecially designed to facilitate penetration by the chest tube. Thispenetration region is a weakened part of the heat seal or a speciallydesigned port that opens only to permit the chest tube to penetrate theinner package.

[0013] To facilitate placement of the chest tube, a specialized cutteris configured to perform the initial incision into the chest wallwithout penetrating below the level of the ribs. This specialized cuttercomprises safety features to prevent premature deployment and to preventcutting too deeply into the chest. This cutter is actuated by manual,electrical or hydraulic/pneumatic force. It may be configured to be apositive displacement cutter or it may be a punch that is loaded andfired or activated under pre-determined force.

[0014] The chest tube comprises a short insertion portion (the distalsegment intended and adapted for insertion into the body of the patient)and a stop to prevent it from being inserted too far into the patient.The short insertion portion has a blunt distal end and is capable ofbeing inserted into a fenestration or incision in the chest wall thatwas created by either a scalpel and blunt dissection as would beperformed by a gloved finger, a Kelly clamp, or a specialized trocar andobturator. The short chest tube is inserted through the incision intothe chest cavity. The short chest tube projects through the skin, fat,fascia, between the ribs, and finally through the pleural lining. Thetip of the chest tube is soft or blunt or both, and contains no edges orroughness that might erode underlying tissues. The short chest tube isterminated on its proximal segment (proximal to the stop) with amanually openable and closeable valve or it is terminated with a one-wayvalve that permits only removal of fluids and air from the chest cavity.The short chest tube comprises a flange that prevents excessivepenetration into the chest cavity. The flange is designed to stop at thelevel of the skin surface, or, in another embodiment, the flange issmaller and is inserted into the incision but does not penetrate belowthe level of the top of the ribs.

[0015] In yet another embodiment, should lateral penetration of thechest tube be desirable, the short chest tube comprises a trocar andobturator that bluntly penetrates the incision to a pre-determined depthsuch that it is depth-limited. The trocar further comprises a rightangle turn at its distal end that serves to deflect a secondary longerchest tube that is placed through the trocar and which extends laterallyin the pleural space to the desired location. The trocar and secondarychest tube comprise a seal system to prevent gas passage between the twocomponents. The trocar further comprises an angular orientation markerthat provides an indication to the operator of the direction where thesecondary chest tube will be deflected. The orientation markers may bealigned by the practitioner to point to the head or the feet (or otheranatomical landmark) so that the deflection is always in apre-determined direction.

[0016] The short chest tube may be installed on a patient by unskilledor relatively unskilled medical personnel to treat a trauma pneumothoraxin the field. It cannot be placed unsafely and thus paramedics orEmergency Medical Technicians (EMTS) may install the chest tube intopatients while they are in the field or the emergency department. Theshort chest tube is preferably coupled with a specialized blunt orautomatic tissue dissector that safely dissects an incision through theribs.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017]FIG. 1A illustrates a side view of a chest tube.

[0018]FIG. 1B illustrates a lateral cross-section of the central area ofthe chest tube comprising a generally circular cross-sectional profile.

[0019]FIG. 1C illustrates a lateral cross-section of the central area ofthe chest tube comprising a generally elliptical cross-sectionalprofile.

[0020]FIG. 2A illustrates a side view of the distal tip of the chesttube with a blunt trocar or obturator in the advanced configuration sothat the sharp cutter edge of the trocar is protected.

[0021]FIG. 2B illustrates a side view of the tip of the chest tube withthe blunt trocar or obturator in the retracted configuration so that thesharp edge of the cutter is exposed.

[0022]FIG. 2C illustrates a side view of the tip of the chest tube withthe blunt trocar or obturator and the cutting blade retracted andremoved back through the proximal end of the chest tube.

[0023]FIG. 3A illustrates a double aseptic package around the chesttube.

[0024]FIG. 3B illustrates the aseptic package with the outer layerremoved.

[0025]FIG. 3C illustrates the aseptic package with the chest tubeadvanced out through the inner layer of the package.

[0026]FIG. 4 illustrates the chest tube advanced into a wound in thethoracic wall of a patient or other animal.

[0027]FIG. 5A illustrates a top view of a protective wound disc.

[0028]FIG. 5B illustrates a top view of the protective wound disc withits straps wrapped around and adherent to the chest tube.

[0029]FIG. 6A illustrates a side view of a chest wall punch, with aretracted blade.

[0030]FIG. 6B illustrates a side view of a chest wall punch with theblade advanced.

[0031]FIG. 6C illustrates a bottom view of a chest wall punch with theblade advanced.

[0032]FIG. 7 illustrates a side view of a chest tube, comprising a blunttrocar suitable for penetrating the package and bluntly dissecting intothe chest of the patient.

[0033]FIG. 8A illustrates a top view of a chest tube in a packagecomprising an integral protective wound disc and tie down straps.

[0034]FIG. 8B illustrates a top view of a chest tube in a packagecomprising an integral protective wound disc and tie down straps alongwith an integral pleural drainage system.

[0035]FIG. 9A illustrates a side view of an expandable sheath and bluntobturator.

[0036]FIG. 9B illustrates a bottom view of the expandable sheath andblunt obturator.

[0037]FIG. 9C illustrates a side view of the expandable sheath with theblunt obturator removed and a tapered expanding obturator just beinginserted.

[0038]FIG. 9D illustrates a side view of the expandable sheath with thetapered expanding obturator fully inserted so that the collet-like splitsheath sides are fully expanded.

[0039]FIG. 9E illustrates a bottom view of the expandable sheath withthe tapered expanding obturator fully inserted.

[0040]FIG. 10A illustrates a side view of a short chest tube, shownplaced through a cross-sectional view of the outer chest wall.

[0041]FIG. 10B illustrates a side view of a short deflecting trocar andchest tube placed into a thorax or chest wall of a patient.

DETAILED DESCRIPTION OF THE INVENTION

[0042]FIG. 1A illustrates a side view of a chest tube 10 of the presentinvention. The chest tube 10 comprises a length of cannula tubing 12, anoptional integral valve 13, a plurality of drainage ports 14, anoptional region of gripping surface 15 on the cannula tubing 12, adrainage lumen 16, a drainage connector 18, a cutter 20, a cutter handle22, an obturator 24, an obturator handle 26 a cutter control mechanism28, an obturator control rod 30 (see FIGS. 1B and 1C), and a malleableshaft 32. The cannula tubing 12 is an axially elongate hollow tubeaffixed at the proximal end to a drainage connector 18. The central orthrough lumen of the drainage connector 18 is in communication with thelumen 16 of the chest tube 10. The drainage ports 14 are penetrationscommunicating from the outside of the cannula tubing 12 and are incommunication with the inner lumen 16. The cutter 20 is affixed to thedistal end of the cutter control mechanism 28. The cutter controlmechanism 28 is slideably affixed within the central or drainage lumen16 of the cannula tubing 12. The cutter handle 22 is affixed to theproximal end of the cutter control mechanism. The obturator 24 isaffixed to the distal end of the obturator control rod 30, which isslideably mounted within the drainage lumen 16 of the cannula tubing 12.The obturator handle 26 is affixed to the proximal end of the obturatorcontrol rod 30. The malleable shaft 32 is affixed to or integral to thecannula tubing 12 and runs along at least a portion of the length of thecannula tubing 12. The obturator control rod 30 and the cutter controlmechanism 28 both traverse the cannula tubing 12 from approximately itsproximal end to approximately its distal end. The valve 13 is optionaland is optionally configured integrally to the cannula tubing 12 orremovably affixed to the drainage connector 18. The gripping surface 15is integral to the cannula tubing 12 or it is optionally a separatestructure that is movably able to grip the cannula tubing 12.

[0043] Further referring to FIG. 1A, the chest tube 10 is designed to beplaced within a patient's chest and into the patient's chest through anincision in the patient's chest to provide for drainage. Usingadditional components such as a stopcock or one-way valve 13, the chesttube prevents backflow of air or contaminants back into the chest. Suchbackflow of air or contaminants could lead to a pneumothorax orinfection.

[0044] The valve 13 comprises a closeable central orifice that is alsoopenable permitting the obturator control rod 30, the cutter controlmechanism 28, the cutter 20 and the obturator 24 to pass therethrough.The valve 13 is either a one-way valve permitting flow only from thedistal tip of the chest tube 10 and not retrograde back toward thedistal tip of the chest tube 10 (a duckbill valve, for example) or astopcock type valve (a ball valve). The valve 13 may be integral to thechest tube 10 or a separate component added proximal to the drainageconnector 18.

[0045] The gripping surface 15 may be a region of roughness on thesurface of the cannula tubing 12. This roughness may be created by aseries of protrusions or depressions in the surface of the cannulatubing 12, or any other texturing or knurling. The gripping surface 15may also be a separate structure that is slidably, concentricallyaffixed to the cannula tubing. When the gripping surface 15 is withdrawnproximally, it slides relative to the cannula tubing 12. When thegripping surface 15 is advanced distally, it grips the cannula tubing 12in the same manner as a jamb cleat and advances the cannula tubing 12distally.

[0046] The materials used in the manufacture of the cannula tubing 12 ofthe chest tube 10 include but are not limited to polyvinyl chloride,PEBAX, polyurethane, polyester, polyethylene, PEEK, polypropylene,polytetrafluoroethylene, polyetheretherketone, fluorinated ethylenepropylene, polytetrafluoroethylene-perfluoromethylvinylether andsilicone rubber. In order to minimize the risk of kinking, the wall ofthe cannula tubing 12 may be extruded with integral spiral or braidedreinforcements manufactured from materials such as but not limited tostainless steel wire, polyimide strands and the like. The cannula tubing12 may be manufactured from materials with variable durometer orhardness. For example, the proximal end of the cannula tubing may be ofharder durometer or thicker wall construction to make that area stifferthan the distal end, thus enhancing pushability and column strength ofthe chest tube 10.

[0047] The obturator control rod 30 and the cutter control mechanism 28possess column strength and are inelastic in tension. The obturatorcontrol rod 30 and the cutter control mechanism 28 are, however flexibleto at least some degree and allow bending of the chest tube 10 tominimize the risk of perforating internal organs on the patient whilethe chest tube 10 is being inserted. The obturator control rod 30 andthe cutter control mechanism 28 are fabricated from materials such as,but not limited to, stainless steel, nitinol, Elgiloy and the like. Thestructures of the obturator control rod 30 and the cutter controlmechanism 28 are a solid or tubular axially elongate metal or,preferably, a coil or double helix or a braided reinforcement with apolymer coating or coextrusion. Such polymer coatings include, but arenot limited to, Pebax, PVC, PEEK, PTFE, PET, PETG, polyethylene,polypropylene and the like.

[0048] The interior walls of the tube 12, which form the exterior of thedrainage lumen 16 and the distal ports are optionally coated withanti-thrombogenic materials to minimize the risk of thrombus. Theanti-thrombogenic materials include but are not limited to heparin. Theanti-thrombogenic materials are mechanically, covalently or ionicallybonded to the material of the tube 12. The valve 13 and the inner lumenof the drainage connector 18 may also be coated with similaranti-thrombogenic agents. The exterior of the tube 12 as well as theinterior surfaces of the chest tube 10 are optionally coated withantibiotics to minimize the risk of infection. This is especiallyimportant in contaminated environments. Such antibiotics include but arenot limited to erythromycin, amoxicillin, sulfa drugs and the like.

[0049] The diameter of the cannula tubing 12 ranges from 1 mm to 30 mmand preferably between 2 mm and 15 mm. The length of the cannula tubing12 ranges between 10 cm and 200 cm and most preferably ranges between 30cm and 100 cm.

[0050] The malleable shaft 32 is preferably a length of stainless steelor other metal that is embedded within the wall of the cannula tubing12. This malleable shaft may or may not be removable from the chest tube10. The malleable shaft 32 extends along at least a portion of thecannula tubing 12 but preferably extends along the full length of thecannula tubing 12. The malleable shaft 32 is sized so that it may bebent by manual force but resists bending by resilient or elastic forcesimposed thereon by the cannula tubing 12.

[0051] The drainage connector 18 is preferably fabricated from materialssuch as but not limited to polycarbonate, polyvinyl chloride,polyethylene, polypropylene and the like. The drainage connector 18 ispreferably insert molded or affixed using adhesives to the cannulatubing 12. The drainage connector 18 preferably comprises a singlethrough lumen. The drainage connector 18 may, however, be “Y” shaped ortrident shaped and have multiple connections. Such connections typicallyuse hose barb type fittings but may also have Luer type fittings orother bayonet or threaded connections for interface with otherequipment. The drainage connector 18 is sized so that the cutter controlmechanism 28 and the obturator control rod 30 may be slideably passedtherethrough. The drainage connector 18, preferably is sized so that thecutter 20 and obturator 24 may be completely removed from the chest tube10.

[0052] The cutter 20 is preferably a circular cutter with its edgebeveled to the outside. A circular cutter is also known as a trephine.The plane of the front edge of the circular cutter 20 is preferably notorthogonal to the axis of the tube 12 of the chest tube 10. The plane ofthe front edge of the circular cutter 20 is, preferably, disposed at anangle between 5 degrees and 60 degrees from the plane that is orthogonalto the axis of the chest tube 10.

[0053]FIG. 1B illustrates a lateral cross-section of the central area ofthe chest tube 10 with the cannula tubing 12 cross-section showing themalleable shaft 32 as an integral part of the tubing. The drainage lumen16 of cannula tubing 12 has the cutter control mechanism 28 andobturator control rod 30 running co-axially throughout the length ofsaid lumen 16. The cross-sectional outer profile of the cannula tubing12 is generally circular.

[0054]FIG. 1C illustrates a lateral cross-section of the central area ofanother embodiment of the chest tube 10 with the cannula tubing 12cross-section showing the malleable shaft 32 as an integral part of thetubing. The drainage lumen 16 of the cannula tubing 12 further comprisesthe cutter control mechanism 28 and the obturator control rod 30 runningcoaxially throughout the length of said lumen 16. The outer profile ofthe cannula tubing 12 is generally elliptical. An elliptical or roundedrectangular cross-sectional configuration enhances placement of thechest-tube through the intercostal space. By aligning the major axis ofthe ellipse with the direction of the rib disposition and the minor axistransverse to the direction of the ribs, a chest tube of larger drainagecapacity than would normally be allowed by the rib spacing may beinserted between the ribs. Clamps and other devices can be used toinsert a large round chest tube that would not normally fit between theribs except by compressing, or pre-flattening, the tubing cross-sectionprior to insertion. This compression technique is tedious, wastes time,requires sterile equipment and technique, and increases the chance ofcontamination to the patient.

[0055]FIG. 2A illustrates a side view of the distal end of the cannulatubing 12 comprising the cutter 20 and obturator 24, further comprisingthe plurality of drainage ports 14. The cutter 20 and obturator 24 arein the extended or protected position.

[0056] Referring to FIGS. 2A and 1A, the cutter 20 is blunted orprotected by the extended obturator 24 so that the sharp edge or sharptip of the cutter 20 cannot inadvertently cut through the sterilepackaging of the chest tube 10. Such blunting or protection of thecutter 20 by the obturator or blunt tip 24 is selective or controllable.The cutter control mechanism and obturator control rod thus providemeans for longitudinally translating the cutter relative to theobturator, so that it may be selectively extended to put the cuttingedge distal of the obturator. The means for longitudinally translatingthe cutter may also be implemented such that the obturator islongitudinally fixed relative to the cannula tubing, in addition to thelongitudinally slidable obturator illustrated in the figures.

[0057]FIG. 2B illustrates a side view of the distal end of the cannulatubing 12 comprising the cutter 20 and obturator 24, further comprisingthe plurality of drainage ports 14. The cutter 20 is in the extendedposition while the obturator 24 slightly retracted.

[0058] Referring to FIG. 2B, the obturator 22 is slightly retracted toexpose the sharp edge of the cutter 20. The sharp edge of the cutter 20is now useable to punch through the packaging of the chest tube tofacilitate using the tube in emergency conditions or contaminatedenvironments.

[0059]FIG. 2C illustrates a side view of the distal end of the cannulatubing 12 comprising the plurality of drainage ports 14. Referring toFIGS. 1A and 2C, the cutter 20 and obturator 24 are not visible in thisview, as they have been removed from the cannula tubing 12 to open thedrainage lumen 16 in order to perform the designed function of the chesttube 10.

[0060]FIG. 3A illustrates the packaging 40 of the present invention. Thepackaging 40 contains the chest tube 10, and comprises an outer package42 and an inner package 44. The outer package 42 and inner package 44are sterile barriers for the chest tube 10. The inner package 44 and theouter package 42 are, preferably, polyethylene pouches that are closedusing heat seals. The heat seals are typically from {fraction (1/8)}inch to {fraction (1/2)} inch wide around the perimeter of the pouches.The pouches may have regions fabricated from sterile barrier such asTyvek that is suitable for use with ethylene oxide (ETO) sterilizationand allows said ETO to pass into the pouch but prevents contaminationfrom entering the pouch. The weakened area of the seal can be an areawhere the seal is less wide (⅛ to {fraction (1/16)} inch) than the restof the seal.

[0061] In another embodiment, the outer package 42 is a tray fabricatedfrom materials such as but not limited to polystyrene, polyvinylchloride, PETG and the like. The trays are typically thermoformed andare covered with a lid fabricated from Tyvek, PETG, polyethylene or thelike. The lid is preferably heat sealed to a flange at the open end ofthe tray. A tray is advantageous over a pouch in that it offersprotection against crushing that is not provided by the pouch. The tray,however, is larger, heavier, and more difficult to store and dispose.

[0062] The double sterile barrier is intended to give the practitionerthe option of not using the device after initial assessment of thepatient and also for cleanliness and sterility purposes in the field.

[0063]FIG. 3B illustrates the packaging 40 with the outer package 42removed. The inner package 44, further comprising a gripping region 48,is still sealed and protects the chest tube 10 from contamination. Thegripping region 48 provides an area on the package where the operatormay more easily grab the chest tube 10 without slipping. This grippingregion 48 is a high friction region relative to the rest of the package.The gripping region 48 is, in a further embodiment, elastomeric instructure and allows the operator to advance the chest tube 10 while theflexible or inflexible, but inelastic, inner package 44 remainsrelatively undistorted and stable. Suitable materials for fabricatingthe gripping region 48 include, but are not limited to, polyurethane,silicone rubber, thermoplastic elastomers such as C-Flex, and latexrubber.

[0064] In yet another embodiment, the gripping region 48 is movablyattached to the inner package 44 by means of a sliding or moving seal.This sliding or moving seal is a gasket between the gripping region 48and the inner package 44 that prohibits passage of contaminants into theinner package 44 but still permits translation or movement of thegripping region 48 relative to the inner package 44. In one exemplaryembodiment, the gripping region 48 includes a plunger that impinges onthe friction surface 15 on the chest tube 10. The operator depresses theplunger or gripping region 48 and the chest tube 10 is forced againstand through the inner package 44 seal at seal penetration point 46.

[0065]FIG. 3C illustrates the packaging 40 of the chest tube 10 in theinner package 44, further comprising the gripping region 48, with theobturator handle 26 in the partially retracted position. The chest tube10 in this configuration will allow inner package seal penetration 46 tooccur as a result of advancement of the chest tube 10 with the cutter 20exposed, thus penetrating the inner package 44 seal. The obturator 24 isnot visible in this view as it is retracted into the cutter 20 andcannula tubing 12. This allows for cutter 20 penetration through theinner package 44 at the seal penetration point 46 to maintain sterilityuntil advancement and deployment into the patient.

[0066] In another embodiment of the invention, the inner package 44 sealis weakened at a specific area where the chest tube is intended topenetrate the seal. This weakened area is, preferably, visibly markedwith indicia adequate to inform the practitioner of the location of theweakened area (and, thus, the preferred point of exit) to ensure thatthe chest tube penetrates the seal at the weakened area of the innerpackage 44. In yet another embodiment, an openable window is provided inthe inner package 44 where the chest tube is to be advanced out of saidinner package 44. This openable window is, for example, a normallyclosed elastomeric valve (a duckbill or slit membrane) that is priedopen by the chest tube obturator or its cutter. An optional thin seallayer is used to maintain sterility over the openable window, prior toopening.

[0067]FIG. 4 illustrates the method of installing the device 50 into apatient. The chest tube 10 is contained in a sterile inner package 44until ready for deployment into patient 52 through an incision site 54.The access site is first prepared by swabbing or rinsing the area withbetadine or other disinfectant, preferably using standard hospital oremergency procedures. The adhesive patch described below or otherflexible structure further comprising a disinfectant is applied to theregion of the incision. An incision is made in the chest wall using asterile scalpel, punch or other device. A finger or, alternatively,other blunt device is next advanced through the incision to bluntlydissect through the final layers of chest wall into the chest cavity.The blunt device for dissection may optionally be comprised at thedistal tip of the chest tube itself. To deploy the chest tube from itsprotective package, the user first opens and removes the outer sterileor aseptic packaging layer, maintaining the inner package substantiallyintact, so that the chest tube can be placed without the need forsterile gloves to be worn by the user. Next, the user grasps the chesttube and the blunt trocar control knob through the inner layer offlexible packaging. The blunt trocar is manually retracted within thecannula exposing the sharpened distal tip of the cannula. The cannula ispunched through the inner layer of package by way of the sharp tip andthe blunt trocar is now replaced to its protective position. The chesttube is now advanced into the prepared incision in the chest cavity.During deployment, the inner package is left intact over the chest tube,while only the distal end of the tube extends out of the package,ensuring sterility of the chest tube to the maximum extent possible.

[0068]FIG. 5A illustrates an aseptic hold-down patch 60 to be used withthe chest tube. The aseptic hold down patch 60 comprises a penetrationregion 62, a main adhesive region 64, a hold down plate 66, a pluralityof hold down straps 68, an adhesive region 70 on each strap, a pluralityof pull tabs 72, and a plurality of partially completed slits 74 withinthe penetration region 62. As illustrated, the patch is a disc, but itmay be provided in any suitable shape.

[0069] Referring to FIG. 5A, the main adhesive disc 64 is permanentlyaffixed to the hold-down disc 66 with adhesive or other fasteners. Thehold down-straps 68 are affixed to or integral to the hold-down disc 66.The adhesive region 70 is on the hold-down strap 68 and the pull-tab 72is at the end of the hold-down strap 68. The penetration region 62 is atthe center of both the main adhesive disc 64 and the hold down disc 66.The penetration region 62 comprises slits or score lines 74 that passpartially, but not completely, through from the outside. The slits 74may also advantageously fully penetrate the main adhesive disc 64 andthe hold down disc 66. The central area around the penetration region 62is preferably transparent or clear, to permit viewing of the incisionsite while the hold down disc 66 and main adhesive disc 64 are beingadvanced against the patient. The hold down disc 66 and the backbonestructure of the main adhesive disc 64 are fabricated from materialsincluding, but not limited to, cardboard, polystyrene, polyvinylchloride, polyester, polyimide, polyamide, polyethylene, polypropylene,and the like, and they may be integrally formed. While the hold downdisc 66 and the main adhesive disc 64 should be semi-rigid or havereduced flexibility, the hold down straps 68 are preferably of greaterflexibility. The flexibility can be achieved by weaving or knittingstructures of the polymers such as polyester cloth and the like.

[0070] The adhesive region 70 is designed to be fastened to the chesttube to hold the chest tube from being dislodged from the patient. Theadhesive region 70 may alternatively be fabricated using Velcro or otherfastener systems that mate with corresponding systems attached to thechest tube 10. If adhesives are used in the adhesive region 70, a paperor plastic cover strip, removable before use, is desirable to protectthe adhesive.

[0071] The main adhesive disc 64 is coated, on the patient side, with astrong skin adhesive. Such adhesives include cyanoacrylates, butpreferably include aggressive adhesives that may be removed orun-adhered such as those adhesives that are used on the pads ofelectrocardiogram (EKG) electrodes. The adhesive may optionally compriseantigenic, antibiotic or anti-microbial agents such as, but not limitedto, silver azide, silver chloride and the like. The adhesive region is,preferably, covered with a plastic or paper cover that is removed by thepractitioner, prior to adhering the disc to the patient. Prior toadhesion of the hold down disc 60 to the patient, the practitionerpreferably scrubs the area with betadine or other antimicrobial agentusing standard aseptic technique.

[0072]FIG. 5B shows the hold-down disc 60 adhered to the patient 50. Thehold down straps 68 are wrapped around and adhered to the chest tube 10,holding the chest tube 10 in place. The cutter handle 22 and obturatorhandle 26 are not visible in FIG. 5B because they have been removed fromthe chest tube 10.

[0073]FIG. 6A illustrates an incision apparatus 100, with its cutterretracted. The incision apparatus 100 comprises a cutting blade 102, ashaft 104, a chest plate 106, a bearing 108, a housing 110, a spring112, a handle 114, a travel stop 116, a locking mechanism 118, and alock extension 120.

[0074] Referring to FIG. 6A, the cutting blade 102 is permanentlyaffixed to the distal end of the shaft 104 while the handle 114 ispermanently affixed to the proximal end of the shaft 104. The shaft 104slideably moves through bearing 108 that is permanently affixed to thehousing 110, which is further affixed to the chest plate 106. The spring112 biases the shaft 104 so that the cutting blade 102 is retractedwithin the housing 110. The travel stop 116 is affixed to the housing110 and limits travel of the handle 114. The locking mechanism 118 isaffixed to either the chest plate 106 or the housing 110. The lockingmechanism is affixed to the lock extension 120. The lock extension 120selectably engages the cutter 102 to prevent inadvertent advancement ofsaid cutter 102 until desired.

[0075] The cutting blade 102 is preferably fabricated from stainlesssteel and is configured to form a cross or X. The cutting blade 102 mayalso be a single blade or other configuration. The cutting blade 102 maybe pointed or rounded in side view.

[0076] The spring 112 is preferably a concentric coil spring fabricatedfrom stainless steel, Elgiloy, nitinol or other suitable springmaterial. The spring 112 can also be a leaf spring or have anon-concentric configuration.

[0077] The chest plate 106, the housing 110, the handle 114, the lockingmechanism 118, the lock extension 120, and the travel stop 116 arefabricated from polymeric materials including as but not limited to PVC,polycarbonate, acrylic, Delrin, polypropylene, PEEK or other suitablerigid material. The chest plate 106 is preferably transparent and may beprovided with an adhesive on the skin contacting surface 107.

[0078] Referring to FIG. 6A, the chest plate 106 is placed against thechest of the patient so that the center of the chest plate 106 is at thedesired incision point. The chest plate 106 is held against the chest ofthe patient and the locking mechanism 118 is disengaged. Manual force isapplied to the handle 114, which advances the cutter 102 until suchpoint as the handle 114 hits the travel stop 116. Release of manualpressure from the handle 114 causes the spring 112 to retract the blade102 back within the housing. The incision apparatus is designed to cutthrough only the skin, fascia, and fat of the patient and limit deeperadvancement of the blade. The travel stop 116 prevents the blade 112from penetrating lower than the level of the ribs, so as to avoid damageto underlying organs.

[0079]FIG. 6B illustrates a side view of an incision apparatus 100 withits cutter advanced. The incision apparatus 100 comprises a cuttingblade 102, a shaft 104, a chest plate 106, a bearing 108, a housing 110,a spring 112, a handle 114, a travel stop 116, a locking mechanism 118,and a lock extension 120. The locking mechanism 118 has been withdrawnpermitting the cutting blade 102 to be forced beyond the face of thechest plate 106 and into the patient. The handle 114 is now impinging onthe travel stop 116 to prevent the cutting blade 102 from being advancedtoo far beyond the chest plate 106 and thus injure the patient. Thespring 112 is compressed to provide biasing of the cutting blade 102away from the patient after the force on the handle 114 is removed.

[0080]FIG. 6C illustrates a bottom view of an incision apparatus 100.The cutting blade 102 is clearly shown with an “X” configuration in thisembodiment. The shaft 104 and the bearing 108 are visible in this view.

[0081]FIG. 7 illustrates another embodiment of the chest tube 10. Thechest tube 10 comprises a length of tubing 12, an optional valve 13, aplurality of distal openings or drainage ports 14, an optional grippingor friction surface 15, a central lumen 16, a drainage connector 18, anobturator 24, an obturator handle 26, and an obturator control rod 30.The length of tubing 12 comprises a wall and a central lumen 16. Theopenings 14 are holes extending through the tubing wall from theexterior to the central lumen 16. The optional valve is affixed integralto or separate from the tubing 12. The friction surface 15 is integralto the tubing 12 but may be a separate structure slidably disposed overthe tubing 12. The drainage connector 18 is affixed to the proximal endof the tubing 12. The obturator 24 is slidably disposed within thecentral lumen 16 of the tubing 12. The obturator 24 is affixed to thedistal end of the obturator control rod 30. The obturator handle 26 isaffixed to the proximal end of the obturator control rod 30 and extendsoutside the drainage connector 18.

[0082] The obturator 24 could also be termed a nose cone, blunt trocaror other designation. The obturator 24 is wedge shaped but couldalternatively be symmetrical in configuration. The obturator 24 is notsharp enough to cut through skin under pressures up to 20 pounds. Theobturator 24 is, however, able to optionally bluntly dissect muscle andpleural tissue under forces of approximating 20 pounds. The obturator 24is removed from the chest tube 10 by grasping the obturator handle 26and withdrawing said obturator handle 26, which removes the obturator 24by withdrawing the attached obturator control rod 30. The obturatorcontrol rod 30 possesses column strength and resistance to elongationunder tension but is flexible to at least some degree. This flexibilitypermits the obturator control rod 30 and the chest tube 10 to bendduring insertion into the patient, thus minimizing the risk of internalorgan perforation. The obturator control rod 30 optionally possessesvariable flexibility. It is preferred that the obturator control rod 30is more flexible toward the distal end and less flexible toward theproximal end. Referring to FIGS. 1B, 1C and 7, this embodiment of thechest tube 10 may also comprise a malleable shaft 32.

[0083]FIG. 8A illustrates a packaged chest tube system 150 comprising anaxially elongate cannula tube 152 with a central lumen (not shown), aplurality of distal openings 154, an optional one-way valve 156, anoptional shutoff valve 158, a connector 160, an obturator furthercomprising a shaft 162 and a handle 164, a trocar further comprising anaxially elongate cylindrical shaft 166, a beveled tip 168, and a limitstop 170, an inner pouch 172 further comprising a plurality of chevronopening regions 176, a hold down disc 178 further comprising aprotective cover sheet (not shown), a central slit region 180, asubstrate with a clear window area 182 a plurality of hold down ties 184each further comprising a cannula grip region 186, and a skin adherenceregion (not shown), and an outer pouch 188 further comprising aplurality of chevron opening areas 190, and labeling (not shown).

[0084] Referring to FIG. 8A, the cannula tube 152 is an axially elongatetube with a central through lumen having a proximal and a distal end.The distal end of the cannula tube 152 comprises a plurality ofperforations, penetrations, or holes 154 that communicate between theexterior of the cannula 152 and the central lumen. The proximal end ofthe cannula tube 152 is permanently or removably affixed to the one-wayvalve 156 and further removably affixed, preferably in series, to theshutoff valve 158 as well as the connector 160. The shaft 162 of theobturator is removably, and slidably placed through the central lumen ofthe cannula tube 152. The obturator handle 164 is permanently affixed tothe shaft 162 and projects out the proximal end of the cannula tube 152and any attachments including the connector 160. The axially elongateshaft 166 of the trocar is concentrically, slidably, and movably placedover the cannula tube 152. The trocar shaft 166 is sharpened andpreferably beveled on its distal end 168. The proximal end of the trocarshaft 166 is permanently affixed to the limit stop 170, which furthercomprises a central through lumen and slidably moves over the cannulatube 152.

[0085] Further referring to FIG. 8A, the outer pouch 188 is preferablycomprised of an upper layer and a lower layer not shown. The upper layerand the lower layer are preferably heat sealed together so as to form acomplete barrier against microbial contaminants. The band where theupper layer is sealed to the lower layer is called the heat seal 214.The outer pouch 188 preferably comprises one or more openable areas, orchevrons 190, that are comprised by heat seals that are disposeddiagonally across the corners of the outer pouch 188 to permit a user tograb the upper layer separately from the lower layer and tear the twolayers apart at the chevron 190. The outer pouch 188 further preferablycomprises a label, which is either integral or adhered to the outerpouch 188. The inner pouch 172 is fabricated using similar techniques asthe outer pouch 188. Preferably the inner pouch 172 comprises an upperand a lower layer that are heat sealed together with opening chevrons176 and heat seals 212. The inner pouch 172 further comprises a holddown disc 178 that is permanently affixed, removable, or integral to thedistal end of the inner pouch 172. The hold down disc 178 is fabricatedfrom a substrate 182 that forms the main body of the hold down disc 178.The substrate 182 is coated on the distal most side with an adhesivethat is skin compatible and preferably adheres to wet skin. Thesubstrate 182 further comprises a window area, which is a clear ortransparent region permitting visibility through the hold-down disc atleast in its central region. The substrate 182 is partially, orcompletely perforated at its central region in, for example, a cross or“X” shape, to permit easy penetration of the hold-down disc by thedistal tip of the cannula 152. The hold-down disc 178 is preferablyfolded flat so as to be insertable into the outer pouch 188 with aminimum profile. The hold-down disc 178 further is permanently affixedto one or more tie down straps 184 that further are coated with adhesivenear the ends to form adhesive regions 186. The tie-down straps 184 aredisposed within the interior of the inner pouch 172. They may beseparate or pre-attached to the cannula 152. If separate, the adhesiveregions 186 of the tie down straps 184 are covered by a protectivepeel-away layer (not shown).

[0086] The hold-down disc 178, in another embodiment, is a flexible,elastomeric, rigid or semi-rigid piece of polymer, metal, or the likeand is configured with a soft, pliable exterior edge. The hold-down disc178, in this embodiment, is a suction cup that adheres to the patient'sskin by way of suction. A port, valve, and suction bulb for manualevacuation are optionally beneficial to this embodiment in that they canbe used to enhance the vacuum bond created by the basic suction cupdesign.

[0087] The hold down disc 178 is, preferably, affixed to or integral tothe inner pouch 172 and the proximal side of the hold down disc 178comprises part of the interior of the inner pouch 172. Because the innerpouch 178 is flexible, the hold-down disc 178, which is normally in theplane orthogonal to that of the inner pouch 172 or the cannula 152, maybe turned sideways so that it resides in a generally coplanardisposition relative to the inner pouch 178 and cannula 152 duringpackaging, shipping, and storage.

[0088] The trocar comprised by the shaft 166, the limit stop 170 and thesharpened end 168 is very short. The trocar is intended to be forcedinto a skin incision made in the patient's chest. The trocar cannotpenetrate very far because the distance between the sharpened end 168and the distal end of the limit stop 170 is limited. In a preferredembodiment, the limit stop 170 is large in diameter and stops againstthe outside of the skin. The diameter of the limit stop 170 is between 1and 20 cm, and preferably between 2 and 10 cm and more preferablybetween 3 and 6 cm. The length of the shaft 166 is between 1 and 10 cmand preferably between 2 and 5 cm. The length of the shaft 166, in thisembodiment, will need to be tailored to the individual because eachperson has a different amount of fat so different sizes may be required,for example, large, medium, and small. Thus, the distal segment of thecannula which enters the body may be provided in various predeterminedlengths to suit patients of varying physique, and the practitioner mayselect a suitably short device for use after appraisal of the patient.

[0089] In another embodiment of the trocar, the limit stop is smaller indiameter and stops against the outside of the ribs. In this latterembodiment, the limit stop 170 is passed inside a skin incision andthrough fat layers so that it stops at or near the outer region of theribs. The diameter of the limit stop 170 in the latter embodiment isbetween 1 and 5 cm and preferably between 1 and 3 cm. The length of theshaft 166 is between 1 and 5 cm and, preferably between 1.5 and 4 cm sothat it passes through the ribs and into the pleural space but does notproject far into the pleural space. This embodiment avoids much of theissues with regard to amount of body fat on a person and allows for aone-size-fits-all approach, so that the distal segment of the cannulamay be provided in a single predetermined length suitable for safe,stop-limited penetration through the rib cage.

[0090]FIG. 8B illustrates a packaged chest tube system 200 comprising anaxially elongate cannula 152 with a central lumen (not shown), aplurality of distal openings 154, an optional one-way valve 156, anoptional shutoff valve 158, a connector 160, a trocar further comprisingan axially elongate cylindrical shaft 166, a beveled tip 168, and alimit stop 170, an inner pouch 202 further comprising an upper layer anda lower layer (not shown), a plurality of heat seals 212, a drainagevolume 204, a drainage inlet manifold 206, an optional vacuum port 208,an optional stopcock 210, an optional vacuum pump (not shown), a holddown disc 178 further comprising a protective cover sheet (not shown), acentral slit region 180, a plurality of hold down ties 184, a substratewith a clear window area 182, and a skin adherence region (not shown),and an outer pouch 188, further comprising an upper layer and a lowerlayer (not shown), a plurality of heat seals 214, a plurality of chevronopening areas 190, and labeling (not shown).

[0091] The embodiment of FIG. 8B is similar to that of FIG. 8A, exceptthat the inner pouch 202 comprises the drainage volume 204, the drainageinlet manifold 206, the optional vacuum port 208, the optional stopcock210, and the optional vacuum pump. These components are either integralto the inner pouch 202 or are affixed and bonded to the inner pouch 202using heat, solvents, adhesives, ultrasonic welding, or the like.Referring to FIG. 8A, the cannula 152 of FIG. 8B does not comprise anobturator shaft 162 or handle 164, although these could be added, ifdesired. In this embodiment, the extreme distal tip of the cannula 152is advantageously of increased stiffness, or has decreased flexibility,relative to the rest of the shaft 152. In this way, by careful locationof the distal tip of the cannula 152 relative to the trocar shaft 166and sharpened end 168, the cannula 152 serves the function of the bluntobturator.

[0092] Referring to FIG. 8B, the drainage volume 204 serves as anintegral collection device, much like a pleur-evac. The drainage volume204 is connected to the connector 160 of the cannula 152 by way of thedrainage manifold 206. The drainage volume may comprise an optionalstandoff to maintain a finite internal volume for maintenance of apre-applied or generally applied vacuum. The vacuum pump may be a simplemanual bulb or it may be any of the typical manual or electromechanicaldevices available.

[0093] Further referring to FIGS. 8A and 8B, the method allows forplacement of a chest cannula 152 in a patient without the need to usegloves since the cannula 152 and any associated apparatus is handledthrough the protective pouches or bags. The entire system is sterilized.The chest tube 152 and its components, and the inner pouch 202, bothinside and outside, are maintained sterile by the outer pouch 188. Thepatient incision site is first swabbed with iodine, betadine, or otherdisinfectant. An incision is made, with a sharp blade, through the skinand into the fat layers. After removal of the outer pouch 188, the chesttube or cannula 152 may be manipulated through the inner pouch 202. Thehold down disc 178 is adhered to the skin at the incision site. Thetrocar and concentrically mounted chest tube 152 are forced through thecentral slits 180 in the hold-down disc 178 and into the incision. Thetrocar is forced into the incision until the limit stop 170 hits thehold down disc 178. The trocar is withdrawn and the chest tube cannula152 is advanced into the incision. Once placement is acceptable, the tiedown straps 186 are wrapped around the cannula shaft 152 and chestdrainage management can commence.

[0094]FIG. 9A illustrates an expandable trocar 250 comprising a limitstop 252, a plurality of split sleeves 254, an obturator stop 256, anobturator handle 258, and an obturator shaft 260.

[0095] Referring to FIG. 9A, the plurality of split sleeves 254 aredisposed concentrically at their minimum potential diameter. The splitsleeves 254 are embedded in or affixed to elastomeric or malleablematerial that is affixed to a central lumen of the limit stop 252. Theobturator shaft 260 is preferably rounded at its distal end and isaffixed to the obturator stop 256, which is further affixed to theobturator handle 258. The obturator shaft 260 is movably, removably, andslidably disposed within the central lumen described by the splitsleeves 254. The rounded distal end of the obturator shaft 260 ispositioned so that when the obturator stop 256 is against the proximalside of the limit stop 252, the rounded section fully projects beyondthe distal end of the split sleeves 254.

[0096] The number of split sleeves 254 is between 2 and 100, andpreferably between 4 and 50, and more preferably between 6 and 20.

[0097] The region between the split sleeves 254 is either open or it isfilled in with an elastomeric material such as, but not limited topolyurethane, silicone elastomer, thermoplastic elastomer, latex rubber,polyethylene foam, polyvinyl chloride foam, polyurethane foam, and thelike.

[0098]FIG. 9B illustrates a bottom view of the expandable trocar shownin FIG. 9A, further comprising the obturator shaft 260, the plurality ofsplit sleeves 254, the limit stop 252, and the expandable region 262.

[0099] Referring to FIGS. 9A and 9B, the limit stop 252 as well as allcomponents of the obturator are preferably fabricated from metals suchas, but not limited to, stainless steel, cobalt nickel alloys, nitinol,or titanium, or polymeric materials such as, but not limited to,polyethylene, polypropylene, polycarbonate, polyester, polyvinylchloride, ABS, and the like. The elastomeric or malleable material, inwhich the split sleeves 254 are embedded, is preferably a material suchas, but not limited to polyurethane, silicone elastomer, thermoplasticelastomer, latex rubber, polyethylene foam, polyvinyl chloride foam,polyurethane foam, and the like. The split sleeves 254 are fabricatedfrom materials such as, but not limited to, stainless steel, cobaltnickel alloys, nitinol, or titanium, and the like. The elastomericregion in the limit stop 252 embeds the split sleeves 254 and allowsthem to expand under the force of a tapered obturator or centralinsertable mass. In another embodiment, the elastomeric region 262 isreplaced by cantilevered split sleeves 254 that are embedded into thelimit stop 252. The split sleeves 254 are leaf springs and expand in thepresence of a large insertable central mass.

[0100]FIG. 9C illustrates the expandable trocar 250 of FIG. 9A with theobturator components 260, 256, and 258 removed and a large expandingobturator 270 being inserted. The large expanding obturator 270 furthercomprises a tapered region 272, a blunt rounded tip (not shown), astraight shaft 274, and an expanding obturator handle 276. The expandingobturator 270 has not been inserted far enough to cause any expansion ofthe split sleeves 254.

[0101]FIG. 9D illustrates the expandable trocar 250 with the largeexpanding obturator 270 having been fully inserted therein. The splitsleeves 254 have opened up forming a series of fingers that are intendedto pry open or expand tissue. The blunt tip 278 of the expandingobturator 270 is visible in this view. It is preferable that the blunttip 278 not project beyond the distal ends of the split sleeves 254 buta small amount of projection, as shown, is acceptable.

[0102]FIG. 9E illustrates a bottom view of the expandable trocar 250with the large expanding obturator 270 having been fully insertedtherein. The elastomeric or malleable region 262 has become muchnarrower than in the unexpanded state of FIG. 9B, due to the expansionof the embedded split sleeves 254.

[0103] Referring to FIGS. 9A through 9E, the expandable trocar permitsplacement of a small diameter trocar through the thoracic wall, aprocedure which is fairly commonplace and easy. However, by removal ofthe small obturator and full insertion of the large expanding obturator270, the trocar 250 and the hole in the tissue it supports is expandedgreatly and in such a way that a chest tube could be insertedtherethrough. In yet another embodiment of the expandable trocar 250,the obturator shaft 260 is sharpened and capable of cutting through theskin, fat, fascia, and muscle of the patient. The sharp tip on theobturator shaft 260, in this embodiment would be retracted automaticallyby standoffs that projected distally of the limit stop 252 and wereattached to the obturator stop 256 or obturator handle 258. Automaticretraction of the sharp tip of the obturator shaft 260 would permit aone-step procedure or method to punch a hole in the thoracic wall andinsert the trocar 250 through the ribs to the limit stop 252 without theneed of a scalpel or other sharp object to make the initial skinincision.

[0104]FIG. 10A illustrates a short chest tube 300 comprising a cannulatube 302, a plurality of drainage holes 314, a limit stop 304, a tubestandoff 306, a one-way valve 308, a stopcock 310, and a drainageconnector 312. The short chest tube 300 is shown inserted through anincision through a skin 320, a fat layer 322, a layer of fascia 330, aregion of intercostal muscle 324, between the ribs 326, through thepleura 328, and into the pleural space 332.

[0105] Referring to FIG. 10A, the cannula tube 302 is an axiallyelongate hollow tube with a proximal and a distal end. The proximal endof the cannula tube 302 is affixed to the limit stop 304, which isaffixed to the tube standoff 306, which is affixed to the one-way valve308, which is affixed to the stopcock 310, which is affixed to thedistal end of the drainage connector 312. A central through lumen ismaintained from the distal end of the cannula tube 302 to the proximalend of the drainage connector 312 so that fluid can be drained from thethoracic cavity. The one-way valve 308 prevents backflow into thethoracic cavity but opens to provide a through lumen for drainage. Thestopcock 310 provides manual shutoff or opening of the through lumen.The drainage holes 314 communicate between the through lumen and theoutside of the cannula tube 302. The plurality of drainage holes 314 areprovided since a single hole, at the distal tip for example, mightbecome occluded with tissue and drainage could not occur. The pluralityof holes 314 separated by the material of the cannula tube 302 providesa standoff for the tissue and maximizes the surface area for drainage ofthe pleural space.

[0106] Referring to FIG. 10A, the short chest tube 300 may be forcedbetween the ribs 326 and into the pleural space 332 with reduced risk ofdamage to internal organs since the distal end of the cannula tube 302is rounded and blunt. In addition, the length of the cannula tube 302 isshort so that it projects just a small amount into the pleural space332. The cannula tube 302 is provided, for example in several lengths toaccommodate people with different thicknesses of body fat. The diameterof the cannula tube 302 is between 0.25 cm and 4 cm and preferablybetween 0.5 cm and 2 cm. The limit stop 304 prohibits the short chesttube 300 from being advanced too far into the patient and, thus,minimizes the risk of damage to the underlying organs such as the heartand lungs. The lengths and diameters of the limit stop 304 and theconstruction materials is the same as that described for the trocar 250shown in FIGS. 9A through 9E.

[0107]FIG. 10B illustrates a short deflecting trocar and chest tubesystem 350 where the trocar comprises a trocar tube 352, a deflectingtip 354, a limit stop 356, and a sealing handle 358. The chest tubecomprises a cannula 360, a plurality of drainage holes 362, an optionalobturator shaft 364 and an optional obturator handle 366, a one-wayvalve 368, a stopcock 370, and a drainage connector 372. The shortdeflecting trocar and chest tube system 350 is shown inserted through anincision through a skin 320, a fat layer 322, a layer of fascia 330, aregion of intercostal muscle 324, between the ribs 326, through thepleura 328, and into the pleural space 332.

[0108] Referring to FIG. 10B, the short deflecting trocar and chest tubesystem 350 permits placement of a short trocar through the ribs and intothe pleural space. A chest tube cannula 360 is then insertedtherethrough and deflected so that it can route parallel to the plane ofthe chest wall to a desired location. The obturator shaft 364 and theobturator handle 366 are preferably omitted from the system but mayadvantageously be added if additional column strength or steerability isdesired.

[0109] The trocar sealing handle 358 is fabricated from rigid polymerssuch as, but not limited to ABS, PVC, polyethylene, polypropylene,polysulfone, polycarbonate, and the like, and further comprises acentral lumen with an elastomeric seal through which the cannula shaft360 may slidably and movably pass but which seals and prevents thepassage of air or liquid around said cannula shaft 360. The elastomericseal (not shown) is fabricated from materials such as, but not limitedto, silicone elastomer, latex rubber, thermoplastic elastomer,polyurethane, and various closed-cell or open-cell foams. The innersurface of the elastomeric seal is advantageously coated with alubricant such as silicone oil, or the like, to facilitate movement ofthe cannula shaft 360 through the sealing handle 358.

[0110] Referring to FIG. 10C, the limit stop 304 is sized anddimensioned to permit advancement through the fat layer 322 overlyingthe patient's rib cage, but prevent advancement into the narrow spacebetween the ribs 326. In this arrangement, the length of the tube 302distal to the stop is set at a predetermined length corresponding to theaverage thickness of the ribs, so that the distal tip of the tubeextends into the pleural space 332 without significant risk of injuringtissue therein. In all other respects, the chest tube may be similar tothe chest tubes of the previous figures.

[0111] The advantage of the aforementioned devices and methods improvesthe ease with which a chest tube may be placed, especially by lesswell-trained personnel such as paramedics and emergency medicaltechnicians.

[0112] Application of the chest tube system provides improved speed ofapplication of the chest tube, especially in contaminated environments.The application of this chest tube system facilitates damage controlprocedures wherein the patient can be allowed to stabilize prior todefinitive repair of the injuries. The aseptic hold-down disc and theincision apparatus allow for quicker application of the chest tube byparamedics and emergency personnel with less chance of woundcontamination, internal damage to the patient or chest tubedislodgement.

[0113] The present invention may be embodied in other specific formswithout departing from its spirit or essential characteristics. Forexample, the aseptic hold down disk may have more than two straps torestrain the chest tube. The incision apparatus may have a cockingmechanism to retract and then fire the cutter, rather than usingpositive hand pressure to advance the cutter. The described embodimentsare to be considered in all respects only as illustrative and notrestrictive. The scope of the invention is therefore indicated by theappended claims rather than the foregoing description. All changes thatcome within the meaning and range of equivalency of the claims are to beembraced within their scope.

What is claimed is:
 1. An apparatus adapted for chest drainagecomprising: an tube characterized by a proximal end, a distal segmentadapted for insertion into the chest and a lumen communicating from theproximal end to the distal end; a plurality of perforations at thedistal end of the tube communicating between the lumen and the outsideof the tube; a connector at the proximal end of said tube for connectingthe lumen of said tube to drainage apparatus; a cutter located at thedistal end of said tube; an obturator or blunt tip capable ofselectively protecting the sharp edge of said cutter; and means forlongitudinally translating the cutter relative to the obturator suchthat the cutter may be selectively advanced to a position distal to theobturator or blunt tip.
 2. The apparatus of claim 1 wherein said cutteris retractable into the lumen of said tube.
 3. The apparatus of claim 1wherein said cutter is removable from the lumen of said tube.
 4. Theapparatus of claim 1 wherein said obturator or blunt tip is removablefrom said tube.
 5. The apparatus of claim 1 wherein said tube ispackaged inside a sterile barrier that may be pierced with said cutter.6. The apparatus of claim 1 wherein said cutter is operably connected toa handle located near the proximal end of said tube.
 7. A method ofachieving chest drainage at an incision site on the chest wall of apatient, said method comprising the steps of: providing a protectivepatch having one or more straps extending therefrom, adhering aprotective disc with its center over the incision site; making anincision or a hole partially through the thickness of the chest wall atthe incision site; thereafter bluntly dissecting the through theremainder of the thickness of the chest wall at the incision site;providing a chest tube that is sealed within a sterile barrier package,said chest tube characterized by a proximal end, a distal segmentadapted for insertion into the chest and a lumen communicating from theproximal end to the distal segment; manipulating a handle on theproximal end of a chest tube to expose a sharp edge on the distalsegment of said chest tube; puncturing the sterile barrier packagecontaining said chest tube; advancing said chest tube out of saidpackaging; withdrawing said sharp edge on the distal end of the chesttube so that it is no longer exposed; inserting said chest tube into theprepared incision in the patient's chest; removing the sharp edge andits protective cover from the chest tube; attaching said chest tube tostraps attached to the protective patch to hold the chest tube in place;and enabling drainage of liquid through the chest tube from thepatient's chest cavity.
 8. The method of claim 7 wherein the sharp tipand its protective cover are removed from the chest tube prior toinsertion into the patient.
 9. The method of claim 7 wherein the initialincision in the chest wall is made with a punch.
 10. The method of claim7 wherein the straps attached to the protective patch are attached tothe chest tube by way of adhesive.
 11. The device adapted forrestraining a medical device against a patient comprising: a disc orother flat surface that is adhered to the skin of the patient and, atleast one strap affixed to said disc that may further be affixed to themedical device.
 12. The device of claim 11 wherein said medical deviceis a chest tube.
 13. The device of claim 11 wherein said strap isaffixed to the medical device using adhesives.
 14. The device of claim11 wherein said disc further comprises a clearly defined central regionwith partially completed slits created therethrough.
 15. The apparatusof claim 11 wherein said disc further comprises antimicrobial agents onthe side of the disc that is adhered to the patient.
 16. The apparatusof claim 1 wherein said tube further comprises a malleable elementdisposed along at least a part of the length of said tube.
 17. Theapparatus of claim 1 wherein said cutter is a circular cutter with afront cutting edge that is disposed at an angle of between 5 degrees and60 degrees from the plane orthogonal to the axis of the tube.
 18. Anapparatus adapted for chest drainage comprising: an axially elongatetube further comprising a proximal end, a distal end and a throughlumen; a plurality of perforations at the distal end of said tubecommunicating between the through lumen and the outside of the tube; aconnector at the proximal end of said tube for connecting the throughlumen of said tube to drainage apparatus; a package further comprisingan outer package and an inner package; a removable obturator or blunttip, coaxially mounted to the distal end of said tube, wherein saidremovable obturator or blunt tip is able to perforate or fenestrate saidinner packaging of the chest drainage apparatus.
 19. The apparatus ofclaim 18 wherein said disc is pre-attached to said device.
 20. Theapparatus of claim 18 wherein said disc is integral to a portion of thepackaging of said device.
 21. A device adapted for chest drainagecomprising: a drainage tube with a proximal end and a distal end and acentral through lumen; a rigid or semi-rigid trocar through which saiddrainage tube is inserted; and a limit stop disposed in fixedrelationship to the trocar to prevent the trocar from extending beyond apredetermined depth into the chest cavity.
 22. The device of claim 21further comprising a disposable collection chamber, and wherein thedrainage tube is pre-attached to a disposable collection chamber. 23.The device of claim 21 wherein the trocar has a blunt distal end. 24.The device of claim 21 wherein the trocar comprises a deflector whichcauses the chest tube to exit said trocar to the side and not parallelto the long axis of the trocar.
 25. The device of claim 21 wherein thelimit stop is configured to stop against the skin of the patient. 26.The device of claim 21 wherein the limit stop is configured to stopagainst the ribs or tissue underlying the skin.
 27. The device of claim21 further comprising a retractable blade to perform an initial skinincision.
 28. A method of placing a tube into a patient comprising;providing a tube characterized by a distal segment adapted for insertioninto the patient and a proximal segment; packaging the tube in a pouch,said pouch having a patch disposed thereon, said patch being adapted tobe adhesively secured to the patient; while maintaining the pouchsubstantially intact, applying the patch to the skin of the patient; andadvancing the distal segment out of the pouch while inserting the distalsegment of the tube through the patch and into the patient.
 29. A methodof claim 28 further comprising; providing the tube with a bluntobturator slidably disposed within the tube, said blunt obturator havinga tip adapted for blunt dissection of body tissue; advancing the tip ofthe obturator along with the tube, while maintaining the pouchsubstantially intact, into the patient; removing the obturator from thetube.